Unstimulated apheresis for chimeric antigen receptor manufacturing in pediatric/adolescent acute lymphoblastic leukemia patients.
T-cell therapy
adoptive transfer
chimeric antigen receptor
collection efficiency
unstimulated apheresis
Journal
Journal of clinical apheresis
ISSN: 1098-1101
Titre abrégé: J Clin Apher
Pays: United States
ID NLM: 8216305
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
27
04
2020
revised:
22
06
2020
accepted:
22
06
2020
pubmed:
5
8
2020
medline:
4
11
2021
entrez:
5
8
2020
Statut:
ppublish
Résumé
Autologous unstimulated leukapheresis product serves as starting material for a variety of innovative cell therapy products, including chimeric antigen receptor (CAR)-modified T-cells. Although it may be reasonable to assume feasibility and efficiency of apheresis for CAR-T cell manufacture, several idiosyncrasies of these patients warrant their separate analysis: target cells (mononuclear cells [MNC] and T-cells) are relatively few which may instruct the selection of apheresis technology, low body weight, and, hence, low total blood volume (TBV) can restrict process and product volume, and patients may be in compromised health. We here report outcome data from 46 consecutive leukaphereses in 33 unique pediatric patients performed for the purpose of CD19-CAR-T-cell manufacturing. Apheresis targets of 2×10
Substances chimiques
Receptors, Chimeric Antigen
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
398-405Informations de copyright
© 2020 Wiley Periodicals LLC.
Références
Finney OC, Brakke HM, Rawlings-Rhea S, et al. CD19 CAR T cell product and disease attributes predict leukemia remission durability. J Clin Invest. 2019;129(5):2123-2132.
Kunkele A, Brown C, Beebe A, et al. Manufacture of chimeric antigen receptor T cells from mobilized cyropreserved peripheral blood stem cell units depends on monocyte depletion. Biol Blood Marrow Transplant. 2019;25(2):223-232.
Singh N, Perazzelli J, Grupp SA, Barrett DM. Early memory phenotypes drive T cell proliferation in patients with pediatric malignancies. Sci Transl Med. 2016;8(320):320ra323.
Das RK, Vernau L, Grupp SA, Barrett DM. Naive T-cell deficits at diagnosis and after chemotherapy impair cell therapy potential in pediatric cancers. Cancer Discov. 2019;9(4):492-499.
Schulz M, Bialleck H, Thorausch K, et al. Unstimulated leukapheresis in patients and donors: comparison of two apheresis systems. Transfusion. 2014;54(6):1622-1629.
Del Fante C, Scudeller L, Mortellaro C, Viarengo G, Martinasso A, Perotti C. Automated mononuclear cell collection: a feasibility study employing a new software for extracorporeal photopheresis. Vox Sang. 2019;114(8):884-889.
Pascual C, Gonzalez-Arias E, Perez-Corral AM, et al. Mononuclear cell collection for extracorporeal photopheresis by using the "off-line" system: a comparative study between COBE spectra and spectra optia devices. J Clin Apher. 2019;34(4):359-366.
DeSimone RA, Schwartz J, Schneiderman J. Extracorporeal photopheresis in pediatric patients: practical and technical considerations. J Clin Apher. 2017;32(6):543-552.
Dunbar NM, Raval JS, Johnson A, et al. Extracorporeal photopheresis practice patterns: an international survey by the ASFA ECP subcommittee. J Clin Apher. 2017;32(4):215-223.
Even-Or E, Di Mola M, Ali M, et al. Optimizing autologous nonmobilized mononuclear cell collections for cellular therapy in pediatric patients with high-risk leukemia. Transfusion. 2017;57(6):1536-1542.
Even-Or E, Eden-Walker A, Di Mola M, et al. Comparison of two apheresis systems for autologous stem cell collections in pediatric oncology patients. Transfusion. 2017;57(1):122-130.
Sorensen J, Jarisch A, Smorta C, et al. Pediatric apheresis with a novel apheresis device with electronic interface control. Transfusion. 2013;53(4):761-765.
Ali S, Chiang KY, Even-Or E, et al. Comparison between intermittent and continuous leukapheresis protocols for autologous hematopoietic stem cell collections in children. J Clin Apher. 2019;34(6):646-655.
Mielcarek M, Torok-Storb B. Phenotype and engraftment potential of cytokine-mobilized peripheral blood mononuclear cells. Curr Opin Hematol. 1997;4(3):176-182.
Doberschuetz N, Soerensen J, Bonig H, et al. Mobilized peripheral blood stem cell apheresis via Hickman catheter in pediatric patients. Transfusion. 2019;59(3):1061-1068.
Mohammadi AM, Norooznezhad AH, Seghatchian J, et al. Photopheresis of a less than 10-kg child with acute graft versus host disease accompanied with hyperbilirubinemia: a case report. Transfus Apher Sci. 2018;57(3):428-430.
Ceppi F, Rivers J, Annesley C, et al. Lymphocyte apheresis for chimeric antigen receptor T-cell manufacturing in children and young adults with leukemia and neuroblastoma. Transfusion. 2018;58(6):1414-1420.
Zeng F, Huang H, Fu D, Huang Q, Fan L, Wei S. Leukapheresis in 15 patients weighing 20kg or less: a single Centre experience. Transfus Apher Sci. 2017;56(6):889-893.
Bojanic I, Mazic S, Rajic L, Jakovljevic G, Stepan J, Cepulic BG. Large volume leukapheresis is efficient and safe even in small children up to 15 kg body weight. Blood Transfus. 2017;15(1):85-92.
Maitta RW, Vasovic LV, Mohandas K, Music-Aplenc L, Bonzon-Adelson A, Uehlinger J. A safe therapeutic apheresis protocol in paediatric patients weighing 11 to 25 kg. Vox Sang. 2014;107(4):375-380.
Cherqaoui B, Rouel N, Auvrignon A, et al. Peripheral blood stem cell collection in low-weight children: retrospective comparison of two apheresis devices. Transfusion. 2014;54(5):1371-1378.
Empringham B, Chiang KY, Krueger J. Collection of hematopoietic stem cells and immune effector cells in small children. Transfus Apher Sci. 2018;57(5):614-618.
Allen ES, Stroncek DF, Ren J, et al. Autologous lymphapheresis for the production of chimeric antigen receptor T cells. Transfusion. 2017;57(5):1133-1141.
Tuazon SA, Li A, Gooley T, et al. Factors affecting lymphocyte collection efficiency for the manufacture of chimeric antigen receptor T cells in adults with B-cell malignancies. Transfusion. 2019;59(5):1773-1780.
DeSimone RA, Myers GD, Guest EM, Shi PA. Combined heparin/acid citrate dextrose solution a anticoagulation in the Optia continuous mononuclear cell protocol for pediatric lymphocyte apheresis. J Clin Apher. 2019;34(4):487-489.
Yakoub-Agha I, Chabannon C, Bader P, et al. Management of adults and children undergoing chimeric antigen receptor T-cell therapy: best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the joint accreditation committee of ISCT and EBMT (JACIE). Haematologica. 2020;105(2):297-316.
Reinhardt P, Brauninger S, Bialleck H, et al. Automatic interface-controlled apheresis collection of stem/progenitor cells: results from an autologous donor validation trial of a novel stem cell apheresis device. Transfusion. 2011;51(6):1321-1330.
Brauninger S, Bialleck H, Thorausch K, Seifried E, Bonig H. Mobilized allogeneic peripheral stem/progenitor cell apheresis with spectra Optia v.5.0, a novel, automatic interface-controlled apheresis system: results from the first feasibility trial. Vox Sang. 2011;101(3):237-246.
Brauninger S, Bialleck H, Thorausch K, Felt T, Seifried E, Bonig H. Allogeneic donor peripheral blood "stem cell" apheresis: prospective comparison of two apheresis systems. Transfusion. 2012;52(5):1137-1145.
Bartnik K, Maciejewska M, Farhan R, et al. Continuous mononuclear cell collection (cMNC) protocol impact on hematopoietic stem cell collections in donors with negative collection predictors. Transfus Apher Sci. 2018;57(3):401-405.
Klarmann D, Sireis W, Hogardt M, Kempf VA, Seifried E, Bonig H. A validation protocol and evaluation algorithms to determine compatibility of cell therapy product matrices in microbiological testing. Cell Tissue Bank. 2015;16(3):311-318.
Cooling L, Hoffmann S, Herrst M, Muck C, Armelagos H, Davenport R. A prospective randomized trial of two popular mononuclear cell collection sets for autologous peripheral blood stem cell collection in multiple myeloma. Transfusion. 2010;50(1):100-119.
Stenzinger M, Bonig H. Risks of leukapheresis and how to manage them-a non-systematic review. Transfus Apher Sci. 2018;57(5):628-634.
Kishimoto M, Ohto H, Shikama Y, Kikuta A, Kimijima I, Takenoshita S. Treatment for the decline of ionized calcium levels during peripheral blood progenitor cell harvesting. Transfusion. 2002;42(10):1340-1347.
Ohara Y, Ohto H, Tasaki T, et al. Comprehensive technical and patient-care optimization in the management of pediatric apheresis for peripheral blood stem cell harvesting. Transfus Apher Sci. 2016;55(3):338-343.
Sanderson F, Poullin P, Smith R, et al. Peripheral blood stem cells collection on spectra optia apheresis system using the continuous mononuclear cell collection protocol: a single center report of 39 procedures. J Clin Apher. 2017;32(3):182-190.